Immuno procedure for method performance specifications -Reply

Gwen,
Sounds like you were inspected by a clinical lab person!? It's
too bad those CAP checklists leave so much to the inspector's
imagination! You're probably already doing everything a
reasonable inspector expects. We just state in our procedure
how we document all controls tested and run for accuracy. Each
control is then documented on the daily immuno QA sheet. Since
IHC is high complexity, this probably should be signed by a
pathologist, but our chief gave that authority to a supertech
(supervisor or senior level B.S. decreed histotech). Also good
ideas to state in your procedure: which controls are used for what
kinds of tissue, how decalcification affects staining, and cytospin
variations.
Did the inspector give you examples of what he or she expects?
I'd be curious to know.
Beth Morehead
Med. U of SC